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6MP

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Trial Status: Complete

This is a multi-centre randomised phase 2 trials in patients with known BRCA Defective Tumours

SUMMARY

To determine the response rates and toxicity of 6MP with low dose methotrexate in patients with breast, ovarian, fallopian tube or primary serous peritoneal cancer who are known to have a BRCA mutation.

A Phase II Clinical trial in patients with known BRCA Defective Tumours.

6MP is closed to recruitment and is in follow-up.

Objectives

Primary

  • To determine the objective response rate to 6MP/MTX in this patient population.

Secondary

  • To evaluate overall survival after treatment with 6MP/MTX.
  • To evaluate progression free survival (PFS) after treatment with 6MP/MTX.
  • Safety of 6MP/MTX.
  • To study pharmacokinetics of 6MP/MTX in these patient populations.
  • To study the effect of patient pharmacogenomics on thiopurine metabolism.
  • Assessment of feasibility as a multi-centre study.
  • Assessment of quality of life.

TRIAL PUBLICATIONS

The study protocol publication can be found here.

The primary results publication can be found here.